Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study
August
Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study
Sung Han Kim 0 1
Sohee Kim 0 1
Byung-Ho Nam 0 1
Sang Eun Lee 0 1
Choung Soo Kim 0 1
Ill Young Seo 0 1
Tae Nam Kim 0 1
Sung-Hoo Hong 0 1
Tae Gyun Kwon 0 1
Seong Il Seo 0 1
Kwan Joong Joo 0 1
Kanghyon Song 0 1
Cheol Kwak 0 1
Jinsoo Chung 0 1
0 1 Departments of Urology, Center for Prostate Cancer, National Cancer Center , Goyang, Korea, 2 Biometric Research Branch , Center for Prostate Cancer, National Cancer Center , Goyang , Korea , 3 Seoul National University Bundang Hospital, SeongNam, Korea, 4 Asan Medical Center , Seoul , Korea , 5 Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Korea , 6 Pusan National University Hospital , Busan, Korea, 7 Seoul St. Mary's Hospital , Seoul , Korea , 8 School of Medicine, Kyungpook National University , Daegu , Korea , 9 Wonkwang University School of Medicine and Hospital , Iksan , Korea , 10 Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine , Seoul , Korea , 11 Korea Cancer Center Hospital , Seoul , Korea , 12 Seoul National University Hospital , Seoul , Korea
1 Editor: Jung Weon Lee, Seoul National University , REPUBLIC OF KOREA
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Funding: This investigator-initiated research was
supported with funding by a grant from Bayer
Healthcare Pharmaceuticals, Korea (Grant No. Asan
cell carcinoma (mRCC).
To evaluate the efficacy and safety of sorafenib for Korean patients with metastatic renal
patient characteristics, therapy duration, tumor response, disease control rate, and
tolerability were assessed at baseline and at routine follow-ups, and the progression-free survival
(PFS) and overall survival (OS) times and rates were analyzed.
Among all patients, 18 (10.2%) stopped sorafenib treatment for a median of 1.7 weeks,
including 15 (8.5%) who discontinued the drug, while 40 (22.6%) and 12 (6.8%) patients
required dose reductions and drug interruptions, respectively. Severe adverse events (AEs)
or poor compliance was observed in 64 (36.2%) patients, with 118 (7.4%)
During the treatment, one myocardial infarction was observed. The number of
AEs in the first-line sorafenib group was 71 (6.8% of the total 1048 AEs). During a median
follow-up of 17.2 months, the radiologically confirmed best objective response rate, disease
control rate, median PFS, and median OS were 22.0%, 53.0%, 6.4 months (95% confidence
2012-09). The funders had no role in study design,
data collection and analysis, decision to publish, or
preparation of the manuscript. Co-author Ill Young
Seo is employed by Samsung Medical Center.
Coauthor Kwan Joong Joo is employed by Kangbuk
Samsung Hospital. Samsung Medical Center and
Kangbuk Samsung Hospital provided support in the
form of salaries for authors IYS and KJJ, but did not
have any additional role in the study design, data
collection and analysis, decision to publish, or
preparation of the manuscript. The specific roles of
these authors are articulated in the ‘author
contributions’ section.
Competing Interests: This investigator-initiated
research was supported with funding by a grant from
Bayer Healthcare Pharmaceuticals. Co-author Ill
Young Seo is employed by Samsung Medical Center.
Co-author Kwan Joong Joo is employed by Kangbuk
Samsung Hospital. The corresponding author (Dr.
Jinsoo Chung) and one of the co-author named Dr
Choung-Soo Kim have acted as consultants for
Pfizer, Bristol-Myers Squibb, and Taiho, and have
received advisory and/or speaker fees from Bayer,
Bristol-Myers Squibb, and Taiho. There are no
patents, products in development or marketed
products to declare. This does not alter the authors'
adherence to all the PLOS ONE policies on sharing
data and materials. The other authors declare that
they do not have anything to disclose regarding
funding or conflicts of interests with respect to this
manuscript.
interval [CI], 5.2–8.9), and 32.6 months (95% CI, 27.3–63.8) for the total 177
sorafenibtreated patients, respectively, and 23.2%, 56.0%, 7.4 months (95% CI, 5.5–10.5), and not
reached yet (95% CI, 1.0–31.1) for the first-line sorafenib group, respectively.
Conclusions
Sorafenib produced tolerable safety, with a grade 3 AE rate of 7.4% and an acceptable
disease control rate (53.0%) in Korean mRCC patients.
Until the early 2000s, which saw the advent of targeted therapy (TT), metastatic renal cell
carcinoma (mRCC) was considered a dismal disease, owing to its high resistance to chemotherapy
and poor responses (<20%) to cytokine therapy, the first-line systemic therapy for mRCC
patients at that time [1]. Moreover, many patients were unable to receive cytokine therapy,
particularly interleukin-2, due to toxicity, resulting in 5-year overall survival (OS) rates of only
10–22% [2].
After the introduction of several new agents, the standard first-line treatment for advanced
RCC has shifted to TT. Among the TTs, sorafenib (Nexavar, Bayer Heal (...truncated)